510(k) Report

Devices descending from K141953

265 later devices reach Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K240699SCARLET® AC-TiSpineart SA20240—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—